Table 1.
Zilucoplan | Control | All patients | |
---|---|---|---|
N = 54 | N = 24 | N = 78 | |
Male sex—no. (%) | 49 (91) | 19 (79) | 68 (87) |
Ethnicity—no. (%) | |||
African | 4 (7) | 0 | 4 (5) |
Arabian | 3 (6) | 1 (4) | 4 (5) |
Asian | 1 (2) | 0 | 1 (1) |
Caucasian | 46 (85) | 22 (92) | 68 (87) |
Other | 0 | 1 (4) | 1 (1) |
Age at baseline—median (min, max), years | 63 (35, 83) | 64 (50, 85) | 63 (35, 85) |
BMI—mean (SD) | 28 (4) | 30 (4) | 29(4) |
Co-existing conditions—no. (%) | |||
Arterial hypertension | 26 (48) | 10 (42) | 36 (46) |
Diabetes mellitus | 14 (26) | 4 (17) | 18 (23) |
Cardiovascular disease | 9 (17) | 10 (42) | 19 (24) |
Chronic kidney disease | 4 (7) | 0 | 4 (5) |
6-point ordinal scale at baseline—no. (%) | |||
2 Invasive mechanical ventilation | 8 (15) | 2 (8) | 10 (13) |
3 Non-invasive ventilation or high flow oxygen devices | 19 (35) | 8 (33) | 27 (35) |
4 Hospitalized, requiring supplemental oxygen | 26 (48) | 14 (58) | 40 (51) |
5 Hospitalized, not requiring supplemental oxygen | 1 (2) | 0 | 1 (1) |
Admitted to ICU at randomisation—no. (%) | 30 (56) | 12 (50) | 42 (54) |
Days of symptoms at randomisation—median (min, max) | 10 (7, 16) | 10 (6, 13) | 10 (6, 16) |
Days of hospitalization at randomisation—median (min, max) | 3 (1, 8) | 2 (1, 11) | 2 (1, 11) |
PaO2/FiO2 ratio at baseline—mean (SD), mmHg | 169 (94) | 175 (93) | 171 (93) |
A-a gradient at baseline—mean (SD), mmHg | 272 (211) | 237 (208) | 261 (209) |
SOFA score at baseline—no. (%) | |||
1–2 | 29 (57) | 14 (61) | 43 (58) |
3–4 | 14 (28) | 7 (30) | 21 (28) |
5–6 | 1 (2) | 2 (9) | 3 (4) |
7–8 | 7 (14) | 0 | 7 (10) |
Not done | 3 | 1 | 4 |
Laboratory values at baseline—mean (SD) | |||
CRP (mg/L) | 142 (89) | 135 (61) | 140 (81) |
Lymphocyte count (109/L) | 0.9 (0.8) | 0.7 (0.4) | 0.8 (0.7) |
Ferritin (µg/L) | 2608 (1792) | 2258 (1206) | 2500 (1635) |
D-dimers (ng/mL) | 1100 (894) | 1249 (1338) | 1147 (1046) |
LDH (IU/L) | 479 (178) | 492 (167) | 483 (174) |
C5 (µg/L) | 114 (24) | 98 (25) | 110 (25) |
Concomitant medication—no. (%) | |||
Glucocorticoids (at randomisation) | 49 (91) | 18 (75) | 67 (86) |
Glucocorticoid use (during first 28 days) | 49 (91) | 18 (75) | 67 (86) |
Anticoagulants (at randomisation) | 50 (93) | 22 (92) | 72 (92) |
Antibiotics (at randomisation) | 16 (30) | 2 (8) | 18 (23) |
Remdesivir (at randomisation) | 7 (13) | 2 (8) | 9 (12) |
Body mass index (BMI) was calculated as weight in kilograms divided by height in meters squared. Sex and ethnicity were reported by study participant. SD standard deviation, CRP C-reactive protein, LDH lactate dehydrogenase, C5 complement 5, SOFA severity of organ failure assessment, PaO2 partial pressure of arterial oxygen, FiO2 fraction of inspired oxygen